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NCT01705691 · ClinicalTrials.gov registry record · Phase 2

Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer

A Phase 2 study, sponsored by NSABP Foundation.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT01705691 is a Phase 2 study that has completed, run by NSABP Foundation. The registered enrollment target is 50 participants.

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The verdict

NCT01705691, a Phase 2 study, has completed, sponsored by NSABP Foundation.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary aim of the study is to determine the pathologic complete response (ypCR) in breast and axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant regimens.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin
  • DRUG Paclitaxel
  • DRUG Eribulin

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2012-09
Est. Completion 2015-10
Phase Phase 2

Sponsor

NSABP Foundation

44 total trials

What the Registry Record Tells You About NCT01705691

The ClinicalTrials.gov registry entry for NCT01705691 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 44 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT01705691 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01705691 about?

NCT01705691 is a clinical study titled "Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer". NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive n...

What is the current status of trial NCT01705691?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-09. Estimated completion is 2015-10.

What interventions are being tested in trial NCT01705691?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Eribulin (DRUG).

Who is sponsoring clinical trial NCT01705691?

This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.